The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.
After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation. Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires. sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05) n \> \[ μ√ π(1- π) + v√ π0(1- π0)\]2 / (π - π0) n \> 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
music is applied during anaesthesia using headphones
music is not applied, only headphones are placed
University Children's Hospital
Zurich, Canton of Zurich, Switzerland
Occuring of a behaviour change
Patients are followed during the first 4 weeks after the operation by parents using a questionnaire in order to detect behaviour changes after the operation.
Time frame: patients are followed during the first 4 weeks after the operation
occurring of postoperative vomiting
Time frame: baseline
occurring of postoperative vomiting
Time frame: 15 min after arrival at the recovery room
occurring of postoperative vomiting
Time frame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Time frame: baseline
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Time frame: 15 min after arrival at the recovery room
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Time frame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Time frame: baseline
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Time frame: 15 min after arrival at the recovery room
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rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Time frame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room